BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 PRO SYNCHRON SYSTEM

    MDR report key: 5161879 · Received October 20, 2015

    Report

    Report Number
    2050012-2015-00386
    Event Type
    Malfunction
    Date Received
    October 20, 2015
    Date of Event
    October 1, 2015
    Report Date
    October 1, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K103842
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE DETERMINED THE REAGENT PROBE TUBING WAS WORN AND LEAKED. THE FSE REPLACED THE TUBING TO RESOLVE THE ISSUE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THEIR UNICEL DXC 800 PRO SYNCHRON SYSTEM REAGENT PROBE B TUBING BROKE AND LEAKED INTO THE INSTRUMENT. THE OPERATOR WORE PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES AND A GOWN WHILE TROUBLESHOOTING. THERE WAS NO REPORT OF OPERATOR INJURY OR ADVERSE EFFECT AS A RESULT OF THIS EVENT. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692272 UNICEL DXC 800 PRO SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1